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Found 8825 cases where Vaccine is PNC13

Case Details (Reverse Sorted by Appearance Date)

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VAERS ID:501515 (history)  Vaccinated:2013-08-20
Age:0.3  Onset:0000-00-00
Gender:Female  Submitted:2013-09-03
Location:Foreign  Entered:2013-09-05, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Low birth weight baby
Diagnostic Lab Data: 21-AUG-2013, Body temperature, 38.5 Centigrade; 21-AUG-2013, Body temperature, 39.7 Centigrade
CDC 'Split Type': 2013243340
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH12H04A SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: This is a spontaneous report from a contactable pediatrician via a Pfizer sales representative. A 4-month-old female patient of unspecified ethnicity received PREVENAR (Lot Number: 12H04A) subcutaneous on 20Aug2013 at 0.5 ml single dose. Medical history included ongoing low weight baby. The patient''s concomitant medications were not reported. On 21Aug2013, the patient experienced exanthema generalized and pyrexia. The clinical course was as follows: On 20Aug2013, PREVENAR was given. On 21Aug2013, around 2AM, pyrexia of 38.5 degrees Centigrade and exanthema generalized appeared. On 21Aug2013, around 4AM, body temperature was 39.7 degrees Centigrade. In the morning of 21Aug2013, the patient was brought for outpatient visit at the reporter''s clinic, and then directly by car to another hospital where the was hospitalized immediately as the patient was also a low weight baby. On 21Aug2013, unknown antibiotics were administered at the hospital. On 22Aug2013, pyrexia subsided. On 24Aug2013 exanthema generalized resolved. Hospitalization was prolonged because cough was also noted. The clinical outcome of the event, cough, was unknown. On 28Aug2013the patient was discharged from the hospital. The reporting pediatrician classified the events, pyrexia, exanthema generalized, and cough, as serious for hospitalization and/or hospitalization prolongation and assessed the events , pyrexia and exanthema generalized, as probably related to PREVENAR, commenting that it was reasonable to consider that the events were associated with PREVENAR. The causality of the event, cough, was not provided. Follow-up (30Aug2013): New information reported from the same contactable pediatrician via a Pfizer sales representative includes: patient demographics, lab data, reaction data (added events: pyrexia and cough), treatment received, outcome (recovered), seriousness (hospitalization and/or hospitalization prolongation), and causality (probably related).

VAERS ID:501600 (history)  Vaccinated:2013-07-25
Age:0.2  Onset:2013-07-31, Days after vaccination: 6
Gender:Male  Submitted:2013-09-05, Days after onset: 36
Location:Foreign  Entered:2013-09-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: 2013, Rotavirus vaccine (unspecified); Immunisation; first dose of rotavirus live vaccine (manufacturer not reported) on an unspecified date in 2013.
Diagnostic Lab Data: 05-Aug-2013: prothrombin time 8.5 seconds; coagulation factor V 200%; von Willebrand''s factor antigen (blood group A1, B, AB) 185%; von Willebrand''s factor antigen (blood group O, A2) 185%; D-Dimer-fibrin degradation products 0.70 mg/l; 07-Aug-2013: Thrombocyte count (EDTA blood) 414 G/l; Thrombocyte count (Citrat blood) 433 G/l; Leukocytes 13.4 *10E9/l; Erythrocytes 4.03 *10E12/l; Haemoglobin, 10.8 g/dl; Haematocrit 30.6%; MCV 75.9 fl; 08/05/2013, Body temperature, 36.9 degrees C; Capillary nail refill test, <3 sec; 08/05/2013, Coagulation factor V level, 200%, Increased; 08/06/2013, Coagulation test, Increased; 08/05/2013, Culture stool, negative for enteritis viruses N/A, Negative; 08/05/2013, Fibrin D dimer, 0.70 mg/l, Increased; 08/06/
CDC 'Split Type': WAES1309DEU001820
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME)UNKNOWN MANUFACTURERJ05530IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 0UNLL
Administered by: Other     Purchased by: Other
Symptoms: Capillary nail refill test abnormal, Coagulation factor V level increased, Coagulation test abnormal, Culture stool negative, Fibrin D dimer increased, Fibrinolysis increased, Haematocrit decreased, Haemoglobin normal, Mean cell volume decreased, Petechiae, Platelet count normal, Platelet function test normal, Prothrombin time shortened, Red blood cell count normal, Skin discolouration, Streptococcus test negative, Ultrasound abdomen normal, Ultrasound skull normal, Urine analysis normal, Von Willebrand's factor antigen increased, White blood cell count normal
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad)
Write-up: Case was received from a healthcare professional on 26-Aug-2013 and additional information on 28-Aug-2013. Case is medically confirmed. This case is part of a cluster of two cases (same reporter, same product, same lot-no., different patient, different reaction). Case is linked with not serious case E2013-06370. A male infant received the second dose of rotavirus live vaccine (manufacturer, lot number not reported) on an unspecified date in 2013. Unspecified time later at the age of 11 weeks, he received the first dose of HEXYON (lot-no. J0553-1) IM into the right thigh on 25-Jul-2013. On the same day the patient was vaccinated with the first dose of PREVENAR (Pfizer, lot-no. not reported) into left thigh. Six day later, on 31-Jul-2013 at the age of 12 weeks, the patient developed petechiae on both lower legs. On an unspecified date a streptococcus A quick test, performed by the paediatrician, was negative. On 05-Aug-2013 the patient was hospitalised due to temporary livid colouring of the right leg, which was also observed on the left leg one week before. After changing the child position the discolouration rapidly disappeared with an anamnestic capillary refill time less than 2 seconds. Physical investigation in the hospital showed petechiae at both lower legs (right more than left0 and capillary refill time was less than 3 seconds. Body temperature was 36.9 degrees C. For laboratory results of 5- and 7-Aug-2013, see lab comments. On 06-Aug-2013 coagulation examinations showed slight increased coagulation and fibrinolytic activity (increased D-Dimer). A von Willebrand''s factor deficit could be excluded. On 07-Aug-2013 thrombocyte testing showed normal results. Platelet function test was normal. On 05-Aug-2013 stool sample was negative for entire range of enteritis viruses. On 05-Aug-2013 urine test was normal. On 06-Aug-2013 sonography of brain could exclude an intracerebral bleeding and stasis of CSF. The same day abdominal sonography showed no pathologies. On 07-Aug-2013 dermatologist of the hospital could not establish a final diagnosis. According to the dermatologist due to anamnesis and residual symptoms for example Schonlein-Henoch purpura after vaccination (with differential diagnosis of acute haemorrhagic oedema in childhood) could be considered, but this diagnosis was not reported in the final diagnosis of the discharge letter. Finally diagnosis of petechiae due to vaccination or an unnoticed infection was established. On 07-Aug-2013 the patient was discharged from hospital, completely recovered. According to the reporter, the reaction was possibly related to HEXYON. The patient''s paternal grandmother suffered from bleeding tendency. Previously the patient received the first dose of rotavirus live vaccine (manufacturer not reported) on an unspecified date in 2013. Toleration was not reported. Upon medical review the company judged relevant to code the second dose of rotavirus vaccine as a suspect drug, because considering the infant''s age at vaccination of HEXYON and PREVENAR this was potentially given in a close timeframe.

VAERS ID:501348 (history)  Vaccinated:2013-08-19
Age:1.0  Onset:2013-08-29, Days after vaccination: 10
Gender:Female  Submitted:2013-09-04, Days after onset: 6
Location:Michigan  Entered:2013-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG940593UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.J0032230UNLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Mom called 8/30/13 to report thumb print size red spot at site of varicella vaccine on 8/19/13. Did experience fever 1 week ago, but other family member also ill. Also had PCV 13 that day. Spots at injection site resolved on Sunday.

VAERS ID:501373 (history)  Vaccinated:2013-09-03
Age:0.2  Onset:2013-09-03, Days after vaccination: 0
Gender:Male  Submitted:2013-09-03, Days after onset: 0
Location:Nebraska  Entered:2013-09-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4363AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH742AA0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURJ10280IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG981340IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0009870PO 
Administered by: Private     Purchased by: Public
Symptoms: Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: Patient became inconsolably fussy about 2 hours after vaccinations were administered. No fever, no apparent redness, swelling at the admin sites.

VAERS ID:501390 (history)  Vaccinated:2013-08-27
Age:1.5  Onset:0000-00-00
Gender:Female  Submitted:2013-08-27
Location:Michigan  Entered:2013-09-04, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B136BB3IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB492CA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH681AA2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF940013IMLL
Administered by: Private     Purchased by: Private
Symptoms: Expired drug administered
SMQs:
Write-up: Pt was given a DTaP vaccine on 8/27/13 the vaccine had expired on 8/15/13.

VAERS ID:501405 (history)  Vaccinated:2013-08-16
Age:1.3  Onset:2013-08-16, Days after vaccination: 0
Gender:Female  Submitted:2013-09-04, Days after onset: 19
Location:Missouri  Entered:2013-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B153AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH044673IMRL
Administered by: Private     Purchased by: Private
Symptoms: Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Pt''s leg has been stiff since immunization. No redness or swelling noted at time of administration or during office visit today. Advised to take ibuprofen, cool packs 3-4x per day and massage 3-4 x''s per day.

VAERS ID:501445 (history)  Vaccinated:2013-08-12
Age:1.0  Onset:2013-08-20, Days after vaccination: 8
Gender:Female  Submitted:2013-08-29, Days after onset: 9
Location:Indiana  Entered:2013-09-04, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4486AA2IMLL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.J0010110IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG319372IMLL
Administered by: Private     Purchased by: Public
Symptoms: Fatigue, Irritability, Pruritus, Rash erythematous, Rash generalised, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: 8/21/2013 appt for vomited x 1. 8/20, fussy, tired. Given Pedialyte & Ibuprofen. 8/22 called MD. Rash since 8/21. ? fever. 8/22 appt for rash all over. Red dots. Itching: Rx''d Triamcinolone cream.

VAERS ID:501353 (history)  Vaccinated:0000-00-00
Age:0.3  Onset:0000-00-00
Gender:Male  Submitted:2013-09-02
Location:Foreign  Entered:2013-09-04, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2013248820
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Depressed level of consciousness, Pallor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This is a spontaneous report from a contactable healthcare professional in the semi-annual line listing for 2013, regulatory authority number NO-NOMAAVDRE-FHI-2013-15788. A 3-month-old male received PREVENAR 13 and INFANRIX-POLIO+HIB on an unknown date. He experienced consciousness decreased and pallor on an unknown date. Patient''s outcome was reported as recovered for all events. Causality was assessed as possible. No follow-up attempts possible. No further information expected.

VAERS ID:501365 (history)  Vaccinated:2013-08-23
Age:0.4  Onset:2013-08-23, Days after vaccination: 0
Gender:Female  Submitted:2013-09-02, Days after onset: 10
Location:Foreign  Entered:2013-09-04, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 1st dose, PREVENAR-13
Diagnostic Lab Data: 23-AUG-2013, Body temperature, 38.9 Centigrade; 23-AUG-2013, Body temperature, 39.1 Centigrade
CDC 'Split Type': 2013249158
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blepharospasm, Body temperature increased, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This is a spontaneous report from a contactable nurse. A 5-month-old female patient was administered PREVENAR 13 and INFANRIX HEXA in the morning of 23Aug2013. This was the second time the patient was vaccinated with PREVENAR 13 (no date provided for the first vaccination). The patient medical history and concomitant medications were not reported. On 23Aug2013, in the afternoon, it was noticed that the patient''s body temperature had increased to 38.9 degrees Centigrade. In addition to this, the eyes were twitching and the mother had difficulties in getting contact with the child. The child was rushed via ambulance to the hospital where it was found that the body temperature had increased further to 39.1 degrees Centigrade and the eyes were still twitching. After unspecified therapeutic measures the body temperature decreased and the eye twitching resolved. There were no more episodes after this. The outcome of the event decreased consciousness was unknown. It was also reported that the nurse who administered PREVENAR 13 noticed that the child had received the batch that had been recalled (no batch number provided).

VAERS ID:501367 (history)  Vaccinated:2013-06-07
Age:0.3  Onset:2013-06-07, Days after vaccination: 0
Gender:Female  Submitted:2013-09-02, Days after onset: 87
Location:Foreign  Entered:2013-09-04, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Immune system disorder; 10-MAY-2013, 2nd administration, PREVENAR, Pyrexia; 10-MAY-2013, second dose, PREVENAR, WBC Increased; 10-MAY-2013, second dose, PREVENAR, C-reactive protein increased; 10-MAY-2013, Hib, C-reactive protein increased; 10-MAY-2013, Hib, WBC increased; 10-MAY-2013, Hib, Pyrexia; 10-MAY-2013, Rotavirus vaccine, Pyrexia; 10-MAY-2013, Rotavirus vaccine, WBC increased; 10-MAY-2013, Rotavirus vaccine, C-reactive protein increased; 10-MAY-2013, DTP/IPV, WBC increased; 10-MAY-2013, DTP/IPV, C-reactive protein increased; 10-MAY-2013, DTP/IPV, Pyrexia
Diagnostic Lab Data: 07-JUN-2013, Body temperature, 38 Centigrade; 08-JUN-2013, Body temperature, over 38 Centigrade; 08-JUN-2013, C-reactive protein, 4.4 mg/dl; 08-JUN-2013, C-reactive protein, 2.7 mg/dl; 08-JUN-2013, White blood cell count, 23600 /mm3; 08-JUN-2013, White blood cell count, 26500 /mm3
CDC 'Split Type': 2013181612
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH12H01A2SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein increased, Hyperthermia, Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad)
Write-up: This is a spontaneous report from a contactable pediatrician via a Pfizer sales representative. A 3-month-old female patient received a single third dose of PREVENAR (Lot 12H01A) on 07Jun2013. The patient had no relevant medical history and concomitant medications were not reported. The patient previously received the second dose of PREVENAR; Lot 12F06A subcutaneously on 10May2013, Hib vaccine subcutaneously on 10May2013, rotavirus vaccine orally on 10May2013, and DTP/IPV subcutaneously on 10May2013 with which they developed pyrexia, white blood cell count (WBC) increased and C-reactive protein (CRP) increased on 11May2013 and was hospitalized. The patient experienced hyperthemia on 07Jun2013 (previously reported as on 08Jun2013, the patient developed pyrexia of 38 degrees Centigrade again and hospitalization was decided as a precautionary measure); at the time of the hospital admission, on 08Jun2013, the patient was already recovered from the pyrexia). The clinical course of events was as follows: from the evening of the same date after vaccination on 07Jun2013, the patient''s body temperature was 38 degrees Centigrade. The patient had continuous hyperthermia with body temperature of over 38 degrees C and presented to reporter''s clinic on 08Jun2013. White blood cell count increased to 26500/mm3 and C-reactive protein was 2.7 mg/dL; onset date 08Jun2013. On 08Jun2013, the patient also experienced WBC increased of (23600 /mm3) and CRP increased of (4.4 mg/dl), as with her last vaccination. The patient recovered from white blood cell count increased on an unspecified date in 2013. The outcome of CRP increased was recovering as of 10Jun2013. The patient received intravenous drip of SOLITA T NO.3 at 200mL and ROCEPHIN at 250 g on the day. Due to the significant increase of white blood cell count, the patient was referred to another hospital for hospitalization. The patient was discharged on 13Jun2013 (5th hospital stay). The reporting pediatrician classified the events as non-serious and assessed pyrexia as probably related to PREVENAR, CRP increased as possibly related and assessed hyperthermia and white blood cell count increased as definitely related to the PREVENAR. The reporting pediatrician commented that although a transient fever due to PREVENAR is highly suspected based on the temporal association, the possibility of infection could not be ruled out either. The pediatrician further reported on 03Jul2013 that the patient received single injection and ACT-HIB on 17Jun2013 and on 22Jun2013, pyrexia of 38.5 degrees C developed and on 24Jun2013, WBC count was 23,600 /mm3 and CRP 6.4 mg/dl. The patient was suspected to have an immune system disorder as a primary disease; the patient was planned to be further examined at a hospital. Follow-up (03Jul2013): New information from the same pediatrician through a Pfizer sales representative includes: past vaccine history, clinical course, recent adverse vaccination experience of pyrexia, WBC and CRP increased with ACT-HIB (administered on 17Jun2013), lab data and causality. Follow-up (16Jul2013): This follow-up report is being submitted to amend previously reported information: Amended coding of past drug history and medical history of PREVENAR, Hib, DTP/IPV and rotavirus vaccine. Removed duplicate medical history of pyrexia with rotavirus vaccine. Follow-up (29Jul2013): This follow-up report is being submitted to amend previously reported information: Seriousness criterion of hospitalization for pyrexia was removed because hospitalization was taken as a precautionary measure and the patient had already recovered from pyrexia at the time of hospital admission. Follow-up (28Aug2013): New information reported from the same contactable pediatrician via a Pfizer sales representative includes: patient data (date of birth), detailed event description, new event (event term was changed to hyperthermia from pyrexia with onset date of 07Jun2013), relevant lab data (body temperature of over 38 d

VAERS ID:501368 (history)  Vaccinated:2013-05-10
Age:0.2  Onset:2013-05-10, Days after vaccination: 0
Gender:Female  Submitted:2013-09-02, Days after onset: 115
Location:Foreign  Entered:2013-09-04, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 10-MAY-2013, Body temperature, 37.8 Centigrade, evening; 11-MAY-2013, Body temperature, 38.5 Centigrade, morning; 11-MAY-2013, Body temperature, 38.9 Centigrade, evening; 22-JUN-2013, Body temperature, 38.5 Centigrade; 11-MAY-2013, C-reactive protein, 4.83 mg/dl; 24-JUN-2013, C-reactive protein, 6.4 mg/dl; 11-MAY-2013, White blood cell count, 18200 /mm3; 24-JUN-2013, White blood cell count, 23600 /mm3
CDC 'Split Type': 2013181569
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURERA002C SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEURH1651 SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH12F06A1SCUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0519AE PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein increased, Hyperthermia, Immune system disorder, Mood altered, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Depression (excl suicide and self injury) (broad)
Write-up: This is a spontaneous report from a contactable pediatrician received via a Pfizer sales representative. A 3-month-old female patient of unspecified ethnicity received the second dose of PREVENAR (Lot number 12F06A) subcutaneously, ACT-HIB (Lot Number H1651) subcutaneously, ROTATEQ (Lot number 0519AE) orally, and QUATTROVAC (Lot number A002C) subcutaneously, all in the morning of 10May2013. The patient''s medical history was not reported. The patient''s concomitant medications were not provided. The patient developed hyperthermia (previously reported as pyrexia) on 10May2013 (previously reported as 11May2013) and white blood cell count (WBC) increased and C-reactive protein (CRP) increased on 11May2013. Clinical course was as follows: The patient''s body temperature was 37.8 degrees Centigrade (C) from the evening of 10May2013. In the morning of 11May2013, body temperature was 38.5 degrees C. The baby was not in good mood and sometimes she put out her tongue. Sucking was normal. Body temperature was 38.9 degrees C in the night of 11May2013. The patient was presented and admitted to another hospital on 11May2013. The patient was monitored without antibiotics, however hyperthermia was not subsided. Then, antibiotics (unspecified) were given and hyperthermia was subsided and the patient was discharged on 17May2013 (previously reported as 15May2013). Relevant lab data included white blood cell count of 18200/mm3 and CRP of 4.83 mg/dl on 11May2013. The outcome of the event, hyperthermia, was resolved on 11May2013. The outcome of the events, white blood cell count increased and CRP increased, were resolving as of 13May2013. On 17Jun2013, the patient received a single injection of ACT-HIB. On 22Jun2013, the patient developed pyrexia of 38.5 degrees C and on 24Jun2013, the patient''s WBC count was 23, 600/mm3 and CRP was 6.4 mg/dl. The patient was suspected to have immune system disorder as a primary disease and was planned to be further examined at a university hospital. The events, hyperthermia, WBC count increased and CRP increased were classified as non-serious. The reporting pediatrician assessed the event, hyperthermia as probably related to pneumococcal 7-valent conjugae (changed from as possibly related). The causality assessment of haemophilus b conjugate, rotavirus, diphtheria toxoid, pertussis and poliiomyelitis inactivated, tetanus toxoid were not provided. Follow-up (03Jul2013): New information reported from the same pediatrician via a Pfizer sales representative includes: laboratory data and reaction data. Follow-up (28Aug2013): New information reported from the same contactable pediatrician received via a Pfizer sales representative includes: Patient information (date of birth), drug data (lot numbers for co-suspect vaccines), reaction data (event "pyrexia" changed to "hyperthermia" with onset date of 10May2013, not 11May2013 as previously reported; clinical course details including hospital discharge date which was changed to 17May2013 as previously reporrted; clinical course details including hospital discharge date was changed to 17May2013), lab data, outcome (hyperthermia: recoverded).

VAERS ID:501369 (history)  Vaccinated:2011-11-16
Age:0.4  Onset:2011-11-20, Days after vaccination: 4
Gender:Male  Submitted:2013-09-02, Days after onset: 651
Location:Foreign  Entered:2013-09-04, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 09-MAY-2012, Haemoglobin, 11.8 g/dl; 11-JUL-2012, Haemoglobin, 11.5 g/dl; 26-SEP-2012, Haemoglobin, 12.8 g/dl; 09-MAY-2012, Lymphocyte count, 5500 /mm3; 11-JUL-2012, Lymphocyte count, 4300 /mm3; 26-SEP-2012, Lymphocyte count, 4500 /mm3; 22-NOV-2011, Neutrophil count, 230 /mm3; 02-FEB-2012, Neutrophil count, 1040 /mm3; 09-MAY-2012, Neutrophil count, 100 /mm3; 01-JUL-2012, Neutrophil count, 5300 /mm3; 11-JUL-2012, Neutrophil count, 100 /mm3; 26-SEP-2012, Neutrophil count, 4100 /mm3; 31-JAN-2013, Neutrophil count, 560 /mm3; 09-MAY-2012, Platelet count, 341000 /mm3; 11-JUL-2012, Platelet count, 334000 /mm3; 26-SEP-2012, Platelet count, 352000 /mm3; 22-NOV-2011, White blood cell count, 9680 /mm3; 09-MAY-2012, White blood cell count, 6700 /mm3; 1
CDC 'Split Type': 2013135764
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB219A IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF43114 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acid base balance normal, Adenovirus test, Amylase normal, Anti-thyroid antibody negative, Anti-transglutaminase antibody negative, Antibody test negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Cardiolipin antibody negative, Constipation, Cough, Cytomegalovirus test negative, DNA antibody negative, Epstein-Barr virus test negative, Faeces hard, Gastrooesophageal reflux disease, Haemoglobin normal, Hyperpyrexia, Idiopathic neutropenia, Lymphocyte count increased, Middle insomnia, Monocyte count normal, Neutropenia, Neutrophil count decreased, Parvovirus B19 test negative, Platelet count normal, Pyrexia, Restlessness, Smooth muscle antibody negative, Upper respiratory tract infection, Upper respiratory tract inflammation, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad)
Write-up: This is a spontaneous report received from the foreign Regulatory Authority; regulatory authority report number 202025. A specialized physician (contactable through Regulatory Authority only) reported that a 5-month-old male patient received, at the age of 4-month-old, PREVENAR 13 (Lot Number: F43114; Expiration Date: 28Feb2014) and INFANRIX HEXA (Lot Number: A21CB219A; Expiration Date: 31Oct2013), both administered intramuscularly on 16Nov2011. Relevant medical history and concomitant medications were unknown. The patient was born at term by dystocia delivery (application of suction cup), after normal pregnancy. Birth weight 3870 g, length 51 cm, 35 cm CC. Breastfeeding up to 8 months of life. Weaning at 6 months, well tolerated. Height-weight growth within the reference percentiles. Free diet and varied. Eupeptic. Patient tend to be constipated (hard stools, goat every 1-2 days). Urination normal. Sleep-wake rhythm characterized by frequent nocturnal awakenings and restlessness as young as 6 months of life (attempted treatment with anti-acids for suspected gastroesophageal reflux, without benefit). Two episodes of inflammation of the upper respiratory tract, one of which was treated at home with antibiotics and aerosol therapy. No family history of onco-hematological diseases. Grandmother showed brain aneurysm. On 20Nov2011, the patient experienced hyperpyrexia (reported as higher than 40 degrees Celsius), and on 22Nov2011, the patient experienced neutropenia. On 22Nov2011 a full blood count (CBC) was performed for reported night restlessness which showed monocyte count at 1.45, white blood cells 9680/mm3 and neutrophils 230/mm3 with hemoglobin and platelets normal. Neutropenia was also confirmed in subsequent checks on 23Nov2011, 14Dec2011, 01Jan2012 and 14Jan2012 (during ongoing fever of unknown origin). On 02Feb2012 (during upper respiratory tract infection and fever), the neutrophils were increased to 1040/mm3. The patient was visited on 07Mar2012 and appeared in good condition, with normal cardio-thoracic-abdominal objectivity. On 09May 2012 blood count showed the persistence of neutropenia (white blood cells 6700/mm3, neutrophils 100/mm3, lymphocytes 5500/mm3, hemoglobin 11.8 g/dl, platelets 341000/mm3, also on the same date the following examinations were performed: first indirect detection of antibodies anti neutrophil IgG and IgM: negative; dose IgG, IgA and IgM: normal; Ab anti-transglutaminase IgA negative; serology for CMV infection, parvovirus B19, EBV and Adenovirus: negative; amylase and evaluation of acid-base venous: normal. On 01Jul2012 the patient was taken to the emergency room for fever and Neutrophils were 5300/mm3. On 11Jul2012 were performed the following tests: white blood cells 5300/mm3, neutrophils 100/mm3, lymphocytes 4300/mm3, hemoglobin 11.5 g/dl, platelets 334000/mm3 and second indirect detection of antibodies IgG and IgM anti neutrophils: negative. On 26Sep2012, the patient was visited for cough and fever and examinations carried out on the same day confirmed a good response to the infectious stimulus: white blood cells 10400/mm3, neutrophils 4100/mm3, lymphocytes 4500/mm3, hemoglobin 12.8 g/dl, platelets 352000/mm3, third indirect detection of antibodies anti-neutrophil IgG and IgM negative, smooth muscle antibodies, antinuclear extractable (ENA), anti-neutrophil cytoplasmic antibodies (ANCA), anti-cardiolipin, anti-thyroglobulin, anti-native DNA and anti nucleus on fabric and Hep2 cells: negative. On 23Nov2012 chronic idiopathic neutropenia with good response to infectious stimuli was diagnosed. On 31Jan2013 the white blood cells were 6640/mm3 and neutrophils 560/mm3. On 12Mar2013, the patient was in good general condition. Weight 15,350 kg, length 89.5 cm, no deformities, no skin changes, or back, normal head, fountain ossified, tonsillar tissue present, pharyngeal hyperemia, teeth normal for age. Heart normal, protruding abdomen and manageable, no organomegaly, normal male genitals, testic

VAERS ID:501370 (history)  Vaccinated:2012-11-22
Age:0.4  Onset:2012-11-22, Days after vaccination: 0
Gender:Female  Submitted:2013-09-01, Days after onset: 282
Location:Foreign  Entered:2013-09-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 22-NOV-2012, Body temperature, 39.7 Centigrade; 23-NOV-2012, Body temperature, 40 Centigrade
CDC 'Split Type': 2013247831
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB466B IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF97947 IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1592AA PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bronchiolitis, Pyrexia, Rhinitis
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: This is a spontaneous report from a contactable physician. This is a report received from a foreign regulatory authority. Regulatory authority report number 214815. A 4-month-old female patient of an unspecified ethnicity received PREVENAR (Lot Number: F97947), intramuscular on 22Nov 2012 at 0.5 ml single dose for vaccination, INFANRIX HEXA (Lot Number: A21CB466B), intramuscular on 22Nov2012 at 0.5 ml single dose of vaccination, and ROTATEQ (Lot Number: 1592AA), oral on 22Nov2012 at a single dose for vaccination. The patient medical history was not reported. Concomitant medications included DIBASE. On 22Nov2012, the patient experienced bronchiolitis, fever, and rhinitis. The clinical course was as follows: In the morning of 22Nov2012, the patient received the second dose of vaccine (unspecified). In the afternoon of 22Nov2012, the patient had an onset of fever at 39.7 degrees Centigrade that reached to 40 degrees Centigrade in the morning. The fever was not very sensitive to paracetamol and regressed completely after two days. But there was occurrence of strong rhinitis and after a few days "hospitalization". The patient visited the emergency room for bronchiolitis and was immediately discharged. The patient completely recovered from the fever, rhinitis, and bronchiolitis, on 24Nov2012. The reporter considered the events, fever, rhinitis, and bronchiolitis, as non serious and assessed the event, bronchiolitis, as not correlated with the report.

VAERS ID:501438 (history)  Vaccinated:0000-00-00
Age:0.3  Onset:0000-00-00
Gender:Male  Submitted:2013-09-04
Location:Foreign  Entered:2013-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0919547A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cough, Depressed level of consciousness, Dyspnoea, Hyperhidrosis, Lip swelling, Pyrexia, Swelling, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (NO-NOMAADVRE-FHI-2013-15468) and described the occurrence of decreased consciousness in a 3-month-old male subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline), PREVENAR 13 (non-gsk). On an unspecified date the subject received unspecified dose of INFANRIX-POLIO-HIB (unknown route), unspecified dose of PREVENAR 13 (unknown route). Lot numbers were not provided. At an unspecified time after vaccination with INFANRIX-POLIO-HIB and PREVENAR 13, the subject experienced decreased consciousness, difficulty breathing, cough, fever, sweating, swelling, lip swelling and swelling of tongue. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-POLIO-HIB and PREVENAR 13. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.

VAERS ID:501045 (history)  Vaccinated:2013-08-30
Age:0.6  Onset:2013-08-30, Days after vaccination: 0
Gender:Female  Submitted:2013-08-31, Days after onset: 1
Location:Texas  Entered:2013-09-03, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Cow''s milk allergy
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSHF2K22IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG624342IMRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness to both thighs at site of injections about quarter size. Fever - 102 degrees.

VAERS ID:501179 (history)  Vaccinated:2012-12-05
Age:0.5  Onset:2012-12-12, Days after vaccination: 7
Gender:Male  Submitted:2013-08-27, Days after onset: 257
Location:New York  Entered:2013-09-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURU4527AA2IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG150742IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.H0127592PO 
Administered by: Private     Purchased by: Private
Symptoms: Injection site bruising, Injection site granuloma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Sustained a small granuloma at site of injection. This granuloma with surrounding bruising has persisted and not decreased in size despite warm soaks and compresses. There are not significant motor sequelae other than subcutaneous granuloma.

VAERS ID:501182 (history)  Vaccinated:2013-08-23
Age:0.2  Onset:2013-08-23, Days after vaccination: 0
Gender:Male  Submitted:2013-08-26, Days after onset: 3
Location:New York  Entered:2013-09-03, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Ex preemie; NKDA
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS4HP39 IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.J005672 IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG47424 IMLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB348A PO 
Administered by: Public     Purchased by: Other
Symptoms: Lethargy, Pallor
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt became lethargic with pale lips after the first shot. Signs/symptoms which were reported by mother before the vaccines - mother stated that pt has been getting in this condition when he cries.

VAERS ID:501226 (history)  Vaccinated:2013-08-22
Age:0.2  Onset:2013-08-22, Days after vaccination: 0
Gender:Male  Submitted:2013-08-27, Days after onset: 5
Location:New York  Entered:2013-09-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Mild plagiocephaly (R) parietal and mild torticollis (to Rt)
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4450AA0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG68912 IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0285AE0PO 
Administered by: Private     Purchased by: Private
Symptoms: Screaming
SMQs:, Hostility/aggression (broad)
Write-up: Rec''d PENTACEL, PREVNAR 13, ROTATEQ at 1030A. Went home slept 3 hrs. - woke at 2P - mom called this office at 4P child screaming non-stop x 2h. Advised to give TYLENOL (160/5ml) 2.5 ml - mom called office back at 535P and infant improved and has done fine and was himself after that.

VAERS ID:501266 (history)  Vaccinated:2013-08-26
Age:0.2  Onset:2013-08-28, Days after vaccination: 2
Gender:Male  Submitted:2013-09-03, Days after onset: 6
Location:Louisiana  Entered:2013-09-03
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: CBC, CMP , UA, CXR all normal; Spinal fluid as noted above. Blood cultures neg.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B37ODA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH683AB0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF959420IMRL
Administered by: Private     Purchased by: Private
Symptoms: Bacterial test negative, Blood culture negative, CSF culture negative, CSF protein increased, CSF white blood cell count increased, Chest X-ray normal, Full blood count normal, Metabolic function test normal, Pyrexia, Red blood cells CSF positive, Urine analysis normal, Viral test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Fever developed and persisted. Patient admitted on 08/30/13 and spinal tap showed 600 WBCs and 100RBCs with elevated protein. Blood and spinal bacterial cultures were neg but awaiting viral culture result for herpes.

VAERS ID:501276 (history)  Vaccinated:2013-08-28
Age:0.2  Onset:2013-09-01, Days after vaccination: 4
Gender:Male  Submitted:2013-09-03, Days after onset: 2
Location:North Carolina  Entered:2013-09-03
Life Threatening? No
Died? Yes
   Date died: 2013-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 33 week preemie
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSHF2K20IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.J0064170IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG432200IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0039520PO 
Administered by: Private     Purchased by: Public
Symptoms: Death
SMQs:
Write-up: Found in early morning app 0630 layed down at 2200.

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